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(Last updated: October 14, 2021)
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1
NEAREST SITE: 339 miles
The Angeles Clinic and Research Institute
Los Angeles,CA
VISITS: May require hospitalization
PHASE: I
NCT ID: NCT04025216
CAR-T Immunotherapy for Metastatic Triple Negative & ER-Low, HER2- Breast Cancer that is TnMUC1-Positive
A Phase 1 Open-Label, Multi-Center First in Human Study of TnMUC1-Targeted Genetically-Modified Chimeric Antigen Receptor T Cells in Patients With Advanced TnMUC1-Positive Solid Tumors and Multiple Myeloma Scientific Title
Purpose
To study the safety, best dose, side effects (good and bad), and anti-cancer activity of a new CAR-T cell immunotherapy that targets cancer cells that test positive for MUC1.
Who is this for?
People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer that tests positive for the antigen TnMUC1.
Full eligibility criteria
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- What's being studied?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®) and fludarabine (Fludara®), by IV, once, before the CART-<span class="highlight">T</span> immunotherapy is given</li> <li class="seamTextUnorderedListItem">CART-<span class="highlight">TnMUC1</span>, by IV, once</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for <span class="highlight">treatment</span> schedule. May require hospital stay.</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that <span class="highlight">tests</span> positive for 1%-10% estrogen receptors is called ER-Low.</li> <li class="seamTextUnorderedListItem">This <span class="highlight">trial</span> is enrolling people with <span class="highlight">triple</span> negative as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem"><span class="highlight">CAR</span>-<span class="highlight">T</span> is a personalized immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">The cells are removed from your blood, modified with chimeric antigen receptors (CARs) that allow <span class="highlight">them</span> to attack proteins on cancer cells, and then put back in your body. </li> <li class="seamTextUnorderedListItem">The <span class="highlight">CAR</span>-<span class="highlight">T</span> <span class="highlight">therapy</span> being used in this study <span class="highlight">trains</span> the immune system to attack MUC1-positive cancer cells. </li> <li class="seamTextUnorderedListItem">Before you have the <span class="highlight">CAR</span>-<span class="highlight">T</span> cell <span class="highlight">therapy</span>, you will be given the chemotherapy drugs fludarabine and cyclophosphamide. These drugs are given to prepare your immune system to receive the <span class="highlight">CAR</span>-<span class="highlight">T</span> cells. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other <span class="highlight">types</span> of cancers that <span class="highlight">test</span> <span class="highlight">TnMUC1</span>-positive.</li> <li class="seamTextUnorderedListItem"><span class="highlight">Targets</span> or mutations: <span class="highlight">TnMUC1</span></li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04025216' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/car-t-cell-therapy' target='_blank'>NCI Dictionary of Cancer Terms: CAR T-cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dana-farber.org/cellular-therapies-program/car-t-cell-therapy/faq-about-car-t-cell-therapy/' target='_blank'>Dana-Farber Cancer Institute: CAR T-Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tmunity.com/pipeline' target='_blank'>Drug Company Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/MUC1' target='_blank'>Wikipedia: MUC1</a> </li></ul>
2
NEAREST SITE: 353 miles
City of Hope Medical Center
Duarte,CA
VISITS: May require hospitalization
PHASE: I
NCT ID: NCT03696030
CAR T-Cell Immunotherapy in HER2+ Breast Cancer with Brain or Leptomeningeal Metastases
A Phase 1 Cellular Immunotherapy Study of Intraventricularly Administered Autologous HER2-Targeted Chimeric Antigen Receptor (HER2-CAR) T Cells in Patients With Brain and/or Leptomeningeal Metastases From HER2 Positive Cancers Scientific Title
Purpose
To study the safety, best dose, and effects (good and bad) of a CAR T-cell immunotherapy that is delivered directly into the brain.
Who is this for?
People with metastatic (stage IV) HER2 positive (HER2+) breast cancer with brain or leptomeningeal metastases.
Full eligibility criteria
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- What's being studied?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw to collect white blood cells to make your HER2 <span class="highlight">CAR</span> <span class="highlight">T</span>-cell <span class="highlight">therapy</span> (leukapheresis)</li> <li class="seamTextUnorderedListItem">Surgery to place a device (similar to a chemotherapy port) under your scalp</li> <li class="seamTextUnorderedListItem">HER2 <span class="highlight">CAR</span> <span class="highlight">T</span>-cells, by injection, weekly, 3 <span class="highlight">times</span></li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for <span class="highlight">treatment</span> schedule. Hospital stay may be required.</i> </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Follow up</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Every 2 months for 1 year, then every year for 15 years</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leptomeningeal metastases are when cancer spreads to the membranes surrounding the brain and/or the spinal cord (leptomeninges) or to the cerebrospinal fluid.</li> <li class="seamTextUnorderedListItem"><span class="highlight">CAR</span> <span class="highlight">T</span>-cell <span class="highlight">therapy</span> is a personalized immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">Your blood cells are removed and modified in a lab with chimeric antigen receptors (CARs) so that they can attack a specific protein.</li> <li class="seamTextUnorderedListItem">The <span class="highlight">CAR</span> <span class="highlight">T</span>-cells are then infused back into you while you are hospitalized. </li> <li class="seamTextUnorderedListItem">The <span class="highlight">CAR</span> <span class="highlight">T</span>-cell <span class="highlight">therapy</span> being used in this study <span class="highlight">trains</span> the immune system to attack HER2+ cancer cells.</li> <li class="seamTextUnorderedListItem">You will have surgery to insert a device under your scalp so that the <span class="highlight">CAR</span> <span class="highlight">T</span>-cell <span class="highlight">therapy</span> can be infused directly into your brain.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03696030' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cityofhope.org/physician-news/breast-cancer-car-t-cell-therapy' target='_blank'>City of Hope Trial Information</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/car-t-cell-therapy' target='_blank'>NCI Dictionary of Cancer Terms: CAR T-cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/immunotherapy/car-t-cell1.html' target='_blank'>American Cancer Society: CAR T-cell Therapy and Its Side Effects</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Leukapheresis' target='_blank'>Wikipedia: Leukapheresis</a> </li><li class='seamTextUnorderedListItem'><a href='http://mbcn.org/brain-mets/' target='_blank'>Metastatic Breast Cancer Network: Brain Metastases</a> </li></ul>
3
NEAREST SITE: 353 miles
City of Hope National Medical Center
Duarte,CA
VISITS: May require hospital stay
PHASE: I
NCT ID: NCT04650451
Experimental CAR T-Cell Immunotherapy BPX-603 for Advanced HER2 Positive Breast Cancer
A Phase 1/2, Open-Label, Multicenter, Non-Randomized, Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) In Subjects With Previously Treated Advanced HER2-Positive Solid Tumors Scientific Title
Purpose
To study the safety, best dose and effects (good and bad) of an experimental CAR T-cell immunotherapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have no standard of care treatment options available.
Full eligibility criteria
Contact research site
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BPX-603 (<span class="highlight">CAR</span> <span class="highlight">T</span>-cell immunotherapy), by IV, one <span class="highlight">time</span></li> <li class="seamTextUnorderedListItem">Rimiducid, by IV, weekly</li> <li class="seamTextUnorderedListItem">You may also receive, <span class="highlight">temsirolimus</span>, by IV, one <span class="highlight">time</span></li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for <span class="highlight">treatment</span> schedule. Hospital stay may be required.</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BPX-603 is the experimental <span class="highlight">CAR</span> <span class="highlight">T</span>-cell immunotherapy used in this <span class="highlight">trial</span>.</li> <li class="seamTextUnorderedListItem"><span class="highlight">CAR</span> <span class="highlight">T</span>-cell <span class="highlight">therapy</span> is a personalized immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">Your blood cells are removed and modified in a lab with chimeric antigen receptors (CARs) so that they can attack a specific protein.</li> <li class="seamTextUnorderedListItem">The <span class="highlight">CAR</span> <span class="highlight">T</span>-cells are then infused back into you while you are hospitalized.</li> <li class="seamTextUnorderedListItem">The <span class="highlight">CAR</span> <span class="highlight">T</span>-cell <span class="highlight">therapy</span> being used in this study <span class="highlight">trains</span> the immune system to attack HER2+ cancer cells.</li> <li class="seamTextUnorderedListItem">This <span class="highlight">trial</span> is also enrolling people with other <span class="highlight">types</span> of HER2 positive cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04650451' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/car-t-cell-therapy' target='_blank'>NCI Dictionary of Cancer Terms: CAR T-Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/immunotherapy/car-t-cell1.html' target='_blank'>American Cancer Society: CAR T-cell Therapy and Its Side Effects</a> </li></ul>
4
NEAREST SITE: 353 miles
City of Hope National Medical Center
Duarte,CA
VISITS: 10 visits over 13 months, may require 1 hospital stay
PHASE: I
NCT ID: NCT04660929
CAR Immunotherapy for Advanced HER2 Positive Breast Cancer
A Phase 1, First in Human Study of Adenovirally Transduced Autologous Macrophages Engineered to Contain an Anti-HER2 Chimeric Antigen Receptor in Subjects With HER2 Overexpressing Solid Tumors Scientific Title
Purpose
To study the safety, side effects and anti-cancer activity of the experimental CAR immunotherapy CT-0508.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have no standard treatment options available.
Full eligibility criteria
Contact research site
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- What's involved?
- What's being studied?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw to collect white blood cells to make your personalized <span class="highlight">CAR</span> <span class="highlight">therapy</span> (leukapheresis)</li> <li class="seamTextUnorderedListItem">CT-0508, by IV, 1 or 3 <span class="highlight">times</span>, over 1 week</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for <span class="highlight">treatment</span> schedule. Hospital stay may be required.</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CT-0508 is a <span class="highlight">CAR</span> immunotherapy made from your own immune cells. </li> <li class="seamTextUnorderedListItem">First, your immune cells are removed from your body during a process called leukapheresis. </li> <li class="seamTextUnorderedListItem">Then the immune cells are modified with chimeric antigen receptors (CARs) so they can attack HER2 proteins on cancer cells.</li> <li class="seamTextUnorderedListItem">Finally, the modified immune cells are then infused back into your body. This part of the <span class="highlight">trial</span> may include a hospital stay. </li> <li class="seamTextUnorderedListItem">This <span class="highlight">trial</span> is also enrolling people with other <span class="highlight">types</span> of HER2 positive cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04660929' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://carismatx.com/science/' target='_blank'>Carisma Therapeutics Drug Information Page: CT-0508</a> </li></ul>
5
NEAREST SITE: 682 miles
Fred Hutch/University of Washington Cancer Consortium
Seattle,WA
VISITS: 2-3 visits over 1-2 months; may include hospital stay
PHASE: I
NCT ID: NCT02706392
CAR T-Cell Therapy For Metastatic Triple Negative & ER-Low Breast Cancer that is ROR1 Positive
Phase I Study of Adoptive Immunotherapy for Advanced ROR1+ Malignancies With Defined Subsets of Autologous T Cells Engineered to Express a ROR1-Specific Chimeric Antigen Receptor Scientific Title
Purpose
To assess the safety, effects (good and bad) and best dose of an experimental CAR-T immunotherapy that targets cancer cells that test positive for ROR1.
Who is this for?
People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer that has not responded to other treatment options and that tests positive for ROR1.
Full eligibility criteria
Contact research site
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- What's being studied?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis (blood draw for the collection of cells) </li> <li class="seamTextUnorderedListItem">Chemotherapy (cyclophosphamide and fludarabine), 1 or 2 <span class="highlight">times</span> over 3 weeks</li> <li class="seamTextUnorderedListItem">ROR1 <span class="highlight">CAR</span>-<span class="highlight">T</span> cells, by IV, 1 or 2 <span class="highlight">times</span> over 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Hospital stay may be required</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that <span class="highlight">tests</span> positive for 1%-10% estrogen receptors is called ER-Low.</li> <li class="seamTextUnorderedListItem">This <span class="highlight">trial</span> is enrolling people with <span class="highlight">triple</span> negative as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem"><span class="highlight">CAR</span>-<span class="highlight">T</span> is a personalized immunotherapy made from a patient's white blood cells. </li> <li class="seamTextUnorderedListItem">The blood cells are removed from the patient and then modified with chimeric antigen receptors (CARs) so they can attack specific proteins. The cells are then infused back into the patient in the hospital. </li> <li class="seamTextUnorderedListItem">The <span class="highlight">CAR</span>-<span class="highlight">T</span> <span class="highlight">therapy</span> being used in this study <span class="highlight">trains</span> the immune system to attack ROR1-positive <span class="highlight">tumor</span> cells. </li> <li class="seamTextUnorderedListItem">It is given along with the chemotherapy drugs fludarabine phosphate and cyclophosphamide. These drugs are given to deplete lymph cells. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other <span class="highlight">types</span> of ROR1-positive metastatic <span class="highlight">tumors</span>.</li> <li class="seamTextUnorderedListItem"><span class="highlight">Targets</span> or mutations: ROR1</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02706392' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancertherapyadvisor.com/sabcs-2018/cart-trial-triple-negative-breast-cancer-start-tnbc/article/819085/' target='_blank'>Cancer Therapy Advisor: CAR-T Trial for Triple-Negative Breast Cancer Under Way</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.drsusanloveresearch.org/videos/chimeric-antigen-receptor-t-cell-car-t-therapy' target='_blank'>Dr. Susan Love Research Foundation: Chimeric Antigen Receptor T-Cell (CAR-T) Therap</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pubmed/26874851' target='_blank'>Pubmed: Expression of ROR1 has prognostic significance in triple negative breast cancer.</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.abstracts2view.com/sabcs18/view.php?nu=SABCS18L_1227' target='_blank'>SABCS 2018 Abstract: Trial update (ROR1-CAR)</a> </li></ul>
6
NEAREST SITE: 1643 miles
Texas Children's Hospital
Houston,TX
VISITS: Hospital stay may be required
PHASE: I
NCT ID: NCT03635632
CAR T-Cell Therapy for Advanced Breast Cancer That Tests Positive for GD2
Phase I Study of Autologous T Lymphocytes Expressing GD2-specific Chimeric Antigen and Constitutively Active IL-7 Receptors for the Treatment of Patients With Relapsed or Refractory Neuroblastoma and Other GD2 Positive Solid Cancers (GAIL-N) Scientific Title
Purpose
To study the safety, best dose, anti-cancer activity and side effects (good and bad) of a new CAR-T cell immunotherapy that targets cancer cells that test positive for GD2.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer that tests positive for GD2 and who have already received at least two therapies for advanced disease.
Full eligibility criteria
Contact research site
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- What's involved?
- What's being studied?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw to collect white blood cells to make your personalized <span class="highlight">CAR</span> <span class="highlight">T</span>-cell <span class="highlight">therapy</span> (leukapheresis)</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®) and fludarabine (Fludara®), by IV, at least 24 hours before the <span class="highlight">CAR</span> <span class="highlight">T</span>-cell immunotherapy is given</li> <li class="seamTextUnorderedListItem">C7R-GD2 <span class="highlight">CAR</span> <span class="highlight">T</span>-cell immunotherapy, by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for <span class="highlight">treatment</span> schedule. Hospital stay may be required.</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">CAR</span> <span class="highlight">T</span>-cell <span class="highlight">therapy</span> is a personalized immunotherapy made from your white blood cells. The white blood cells are removed from your body and then modified with chimeric antigen receptors (CARs) so they can attack specific proteins. These white blood cells are then infused into your body. </li> <li class="seamTextUnorderedListItem">The <span class="highlight">CAR</span> <span class="highlight">T</span>-cell <span class="highlight">therapy</span> used in this study <span class="highlight">trains</span> the immune system to attack cancer cells that <span class="highlight">test</span> positive for the protein GD2.</li> <li class="seamTextUnorderedListItem">You will receive the chemotherapy drugs cyclophosphamide (Cytoxan®) and fludarabine (Fludara®) before you receive the <span class="highlight">CAR</span> <span class="highlight">T</span>-cells. This makes it easier for the <span class="highlight">CAR</span> <span class="highlight">T</span>-cells to get into your immune system. </li> <li class="seamTextUnorderedListItem">This study is also enrolling people with other <span class="highlight">types</span> of advanced cancer.</li> <li class="seamTextUnorderedListItem"><span class="highlight">Targets</span> or mutations: GD2</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03635632' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bcm.edu/research/clinical-trials/h-42207' target='_blank'>Baylor College of Medicine Study Page: GAIL-N</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/car-t-cell-therapy' target='_blank'>NCI Dictionary of Cancer Terms: CAR T-Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/treatment-options/car-t-cell-therapy.html' target='_blank'>MD Anderson Cancer Center: T-Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5458232/' target='_blank'>Journal Article: GD2 Expression in Breast Cancer</a> </li></ul>
7
NEAREST SITE: 1643 miles
Baylor St. Luke's Medical Center
Houston,TX
VISITS: May require hospital stay
PHASE: I
NCT ID: NCT03740256
CAR-T Cell Immunotherapy & Immunotherapy Injected Directly into Tumors for Metastatic HER2 Positive Breast Cancer
A First in Human Phase I Trial of Binary Oncolytic Adenovirus in Combination With HER2-Specific Autologous CAR T Cells in Patients With Advanced HER2 Positive Solid Tumors Scientific Title
Purpose
To study the safety, anti-cancer activity and other effects (good and bad) of giving a HER2-specific CAR-T Cell immunotherapy and an immunotherapy injected directly into a tumor.
Who is this for?
People with metastatic (stage IV) HER2 positive (HER2+) breast cancer.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAdVEC, by injection directly into a <span class="highlight">tumor</span>, one <span class="highlight">time</span></li> </ul> <p class="seamTextPara"> followed by </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2-specific <span class="highlight">CAR</span>-<span class="highlight">T</span> Cell <span class="highlight">therapy</span>, by IV, one <span class="highlight">time</span></li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for <span class="highlight">treatment</span> schedule. Hospital stay may be required.</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">CAR</span>-<span class="highlight">T</span> is a personalized immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">The cells are removed from your blood, modified with chimeric antigen receptors (CARs) that allow <span class="highlight">them</span> to attack proteins on cancer cells, and then put back in your body.</li> <li class="seamTextUnorderedListItem">CAdVEC is an oncolytic adenovirus--this means it <span class="highlight">targets</span> and kills cancer cells. It may directly kill cancer cells and stimulate your immune system to go after and kill cancer cells.</li> <li class="seamTextUnorderedListItem">CAdVEC is injected directly into a <span class="highlight">tumor</span>. </li> <li class="seamTextUnorderedListItem">This <span class="highlight">trial</span> is also enrolling people with other <span class="highlight">types</span> of HER2 positive cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03740256' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/what-is-car-t-therapy/' target='_blank'>Metastatic Trial Talk: What is CAR-T Therapy?</a> </li><li class='seamTextUnorderedListItem'><a href='https://ncit.nci.nih.gov/ncitbrowser/pages/concept_details.jsf?dictionary=NCI_Thesaurus&version=20.07d&code=C158743&ns=ncit&type=all&key=null&b=1&n=0&vse=null' target='_blank'>NCI Thesaurus: CAdVEC</a> </li></ul>
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NEAREST SITE: 2561 miles
Memorial Sloan Kettering Bergen (Consent and Follow-Up)
Montvale,NJ
VISITS: At least 2 visits over 3-6 weeks; may include hospital stay
PHASE: I-II
NCT ID: NCT02414269
CAR T-Cell Immunotherapy for Metastatic Breast Cancer That Has Spread to the Pleura
A Phase I Clinical Trial of Malignant Pleural Disease Treated With Autologous T Cells Genetically Engineered to Target the Cancer-Cell Surface Antigen Mesothelin Scientific Title
Purpose
To study the safety and effects (good and bad) of using a new type of CAR T-cell immunotherapy.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the pleura.
Full eligibility criteria
Contact research site
Share with my doctor
Share with my patient
- What's involved?
- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: <span class="highlight">CAR</span> <span class="highlight">T</span>-Cells only</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis (blood draw for the collection of cells) <i class="seamTextEmphasis">followed 3-6 weeks later by:</i></li> <li class="seamTextUnorderedListItem">Acetaminophen and diphenhydramine, by mouth or by IV </li> <li class="seamTextUnorderedListItem">iCasp9M28z <span class="highlight">CAR</span> <span class="highlight">T</span>-cells, by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: <span class="highlight">CAR</span> <span class="highlight">T</span>-Cells with chemotherapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis (blood draw for the collection of cells) <i class="seamTextEmphasis">followed 3-6 weeks later by:</i></li> <li class="seamTextUnorderedListItem">Acetaminophen and diphenhydramine, by mouth or by IV</li> <li class="seamTextUnorderedListItem">iCasp9M28z <span class="highlight">CAR</span> <span class="highlight">T</span>-cells, by IV</li> <li class="seamTextUnorderedListItem">Cyclophosphamide, by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Hospital stay may be required.</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">CAR</span> <span class="highlight">T</span>-cell <span class="highlight">therapy</span> is a personalized immunotherapy made from your own white blood cells. </li> <li class="seamTextUnorderedListItem">The blood cells are removed from you, and then modified with chimeric antigen receptors (CARs) so they can attack specific proteins. </li> <li class="seamTextUnorderedListItem">The cells are then infused back into you while you are hospitalized. </li> <li class="seamTextUnorderedListItem">The pleura is the <span class="highlight">thin</span> layer of <span class="highlight">tissue</span> that covers the lungs and lines the interior wall of the chest cavity. </li> <li class="seamTextUnorderedListItem">This <span class="highlight">CAR</span> <span class="highlight">T</span>-cell <span class="highlight">therapy</span> is designed to <span class="highlight">target</span> proteins found on cancer cells in the pleura.</li> <li class="seamTextUnorderedListItem">The <span class="highlight">CAR</span> <span class="highlight">T</span>-cell <span class="highlight">therapy</span> is given along with acetaminophen and diphenhydramine. These drugs are used to prevent infusion-related reactions.</li> <li class="seamTextUnorderedListItem">This <span class="highlight">trial</span> is also enrolling people with other <span class="highlight">types</span> of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02414269' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.drsusanloveresearch.org/videos/chimeric-antigen-receptor-t-cell-car-t-therapy' target='_blank'>Dr. Susan Love Research Foundation: Chimeric Antigen Receptor T-Cell (CAR-T) Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4744527/' target='_blank'>Pubmed: Mesothelin-Targeted CARs: Driving T cells to Solid Tumors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/publications/targeted-therapy-news/2018/august-2018/early-signs-of-efficacy-seen-with-mesothelin-car-tcell-therapy' target='_blank'>Targeted Oncology: Early Signs of Efficacy Seen With Mesothelin CAR T-Cell Therapy</a> </li></ul>
